koselugo

Generic: selumetinib

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name koselugo
Generic Name selumetinib
Labeler astrazeneca pharmaceuticals lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

selumetinib 25 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-0625
Product ID 0310-0625_b3809b9c-c5d0-44c6-9c21-abcc230f64ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213756
Listing Expiration 2026-12-31
Marketing Start 2020-04-16

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
mitogen-activated protein kinase kinase 1 inhibitors [moa] mitogen-activated protein kinase kinase 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03100625
Hyphenated Format 0310-0625

Supplemental Identifiers

RxCUI
2289418 2289424 2289426 2289428 2723653 2723657 2723659 2723661
UNII
6UH91I579U
NUI
N0000175605 N0000193943 N0000193944

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name koselugo (source: ndc)
Generic Name selumetinib (source: ndc)
Application Number NDA213756 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (0310-0625-28)
  • 60 CAPSULE in 1 BOTTLE (0310-0625-60)
source: ndc

Packages (2)

0310-0625-28 28 CAPSULE in 1 BOTTLE (0310-0625-28) 0310-0625-60 60 CAPSULE in 1 BOTTLE (0310-0625-60)

Ingredients (1)

selumetinib (25 mg/1)

Linked Drug Pages (1)

KOSELUGO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b3809b9c-c5d0-44c6-9c21-abcc230f64ac", "openfda": {"nui": ["N0000175605", "N0000193943", "N0000193944"], "unii": ["6UH91I579U"], "rxcui": ["2289418", "2289424", "2289426", "2289428", "2723653", "2723657", "2723659", "2723661"], "spl_set_id": ["7d042c61-f28f-4ab5-ab10-d7558c0d49ff"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA]", "Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (0310-0625-28)", "package_ndc": "0310-0625-28", "marketing_start_date": "20210611"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0310-0625-60)", "package_ndc": "0310-0625-60", "marketing_start_date": "20200416"}], "brand_name": "KOSELUGO", "product_id": "0310-0625_b3809b9c-c5d0-44c6-9c21-abcc230f64ac", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA]", "Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]"], "product_ndc": "0310-0625", "generic_name": "SELUMETINIB", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KOSELUGO", "active_ingredients": [{"name": "SELUMETINIB", "strength": "25 mg/1"}], "application_number": "NDA213756", "marketing_category": "NDA", "marketing_start_date": "20200416", "listing_expiration_date": "20261231"}